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FDA Drug Recalls

1,739 recalls · Class I, newest first

Class I · High risk Terminated Apr 15, 2015

Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu, Maximum Strength, Two - 6 fl oz (180 mL) bottles Total…

Reason Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the…

Reckitt Benckiser LLC NDC 63824-528-22 D-1368-2015

Class I · High risk Terminated Apr 15, 2015

Mucinex Fast Max Severe Congestion & Cough, Maximum Strength, Dextromethorphan HBr Cough Suppressant, Guaifenesin Expectorant…

Reason Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the…

Reckitt Benckiser LLC NDC 63824-014-66 D-1367-2015

Class I · High risk Terminated Apr 15, 2015

Mucinex Fast Max Day Time Severe Cold and Fast-Max Night Time Cold & Flu Two - 6 fl oz (180 mL) bottles Total -12 fl oz (360…

Reason Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the…

Reckitt Benckiser LLC NDC 63824-526-22 D-1366-2015

Class I · High risk Terminated Apr 15, 2015

Mucinex Fast-Max Cold & Sinus, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Guaifenesin Expectorant…

Reason Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the…

Reckitt Benckiser LLC NDC 63824-016-66 D-1365-2015

Class I · High risk Terminated Apr 15, 2015

Mucinex Fast Max Night Time Cold & Flu, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Diphenhydramine HCl…

Reason Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the…

Reckitt Benckiser LLC NDC 63824-500-66 D-1364-2015

Class I · High risk Terminated Apr 15, 2015

Mucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Dextromethorphan HBr Cough…

Reason Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the…

Reckitt Benckiser LLC NDC 63824-015-66 D-1363-2015

Class I · High risk Terminated Apr 13, 2015

EPINEPHrine HCl 4 mg added to 250 mL 0.9% Sodium Chloride Injection USP (16 mcg per mL), packaged in 250 mL bags, Rx only…

Reason Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were…

Pharmedium Services, LLC NDC 61553-119-61 D-1358-2015

Class I · High risk Terminated Apr 13, 2015

HEPARIN Sodium Injection USP 25,000 USP Units added to 250 mL 5% Dextrose Injection USP (100 units per mL), packaged in 250 mL…

Reason Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were…

Pharmedium Services, LLC NDC 61553-419-02 D-1357-2015

Class I · High risk Terminated Apr 13, 2015

EPINEPHrine HCl 16 mg added to 250 mL 0.9% Sodium Chloride Injection USP (64 mcg per mL), packaged in 250 mL bags, Rx only…

Reason Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were…

Pharmedium Services, LLC NDC 61553-618-61 D-1356-2015

Class I · High risk Terminated Apr 13, 2015

HEPARIN Sodium Injection USP, 12,500 USP Units added to 250 mL 5% Dextrose Injection USP (50 units per mL), packaged in 250 mL…

Reason Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were…

Pharmedium Services, LLC NDC 61553-418-02 D-1355-2015

Class I · High risk Terminated Apr 13, 2015

EPINEPHrine HCl 1 mg added to 250 mL 0.9% Sodium Chloride Injection USP (4 mcg per mL), packaged in 250 mL bags, Rx only…

Reason Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were…

Pharmedium Services, LLC NDC 61553-244-61 D-1354-2015

Class I · High risk Terminated Apr 13, 2015

oxyTOCIN 15 Units added to 250 mL 5% Dextrose Injection USP, packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W…

Reason Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were…

Pharmedium Services, LLC NDC 61553-777-02 D-1353-2015

Class I · High risk Terminated Apr 12, 2015

Testosterone Cypionate 200 mg/mL in Sesame oil, 10 mL amber glass vial, Rx Only, Lot# T-1201S14, Compounded by Strohecker's…

Reason Incorrect Product Formulation: Vials labeled as Testosterone Cypionate 200 mg/mL in Sesame Oil are being recalled because they contains Estradiol…

Stroheckers Inc Pharmacy D-1088-2015

Class I · High risk Terminated Mar 24, 2015

Lactated Ringers Injection, USP, 250mL VIAFELX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road…

Reason Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)

Baxter Healthcare Corp. NDC 0338-0117-02 D-1211-2015

Class I · High risk Terminated Mar 24, 2015

10% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road…

Reason Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)

Baxter Healthcare Corp. NDC 0338-0023-02 D-1210-2015

Class I · High risk Terminated Mar 24, 2015

5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road…

Reason Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)

Baxter Healthcare Corp. NDC 0338-0017-02 D-1209-2015

Class I · High risk Terminated Mar 24, 2015

0.9% Sodium Chloride Injection, USP, in 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts…

Reason Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)

Baxter Healthcare Corp. NDC 0338-0049-02 D-1208-2015

Class I · High risk Terminated Mar 23, 2015

Gemcitabine for Injection, USP, 1 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan…

Reason Presence of Particulate Matter

Mylan Institutional LLC NDC 67457-462-01 D-1334-2015

Class I · High risk Terminated Mar 23, 2015

Gemcitabine for Injection, USP, 2 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan…

Reason Presence of Particulate Matter

Mylan Institutional LLC NDC 67457-463-02 D-1333-2015

Class I · High risk Terminated Mar 23, 2015

Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-Use Vial, Rx only, labeled as a) Manufactured for…

Reason Presence of Particulate Matter

Mylan Institutional LLC NDC 67457-464-20 D-1332-2015

Class I · High risk Terminated Mar 18, 2015

CARBOplatin Injection 450 mg/45 mL (10 mg/mL), 45 mL packaged in a 100 mL Multi-Dose Vial, Rx only, Manufactured for: Mylan…

Reason Presence of Particulate Matter

Mylan Institutional LLC NDC 67457-493-46 D-1331-2015

Class I · High risk Terminated Mar 18, 2015

Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL), 2 mL Single-dose Vial, packaged in 5 x 2 mL vials per carton, Rx only, labeled…

Reason Presence of Particulate Matter

Mylan Institutional LLC NDC 0069-0146-01 D-1328-2015

Class I · High risk Terminated Mar 11, 2015

LACTATED RINGER'S IRRIGATION, USP, 3000 mL flexible container bag, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045…

Reason Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the solution of the primary container, which were subsequently…

Hospira Inc. NDC 0409-7828-08 D-1108-2015

Class I · High risk Terminated Mar 10, 2015

ULTRA ZX DIETARY SUPPLEMENT (Extracto de Naranjo Amargo 70, Extracto de semilla de Sen 47.6, Lagrima de Coix 42, Almidon Medico…

Reason Marketed Without An Approved NDA/ANDA: FDA laboratory analysis confirmed that ULTRA ZX contains undeclared sibutramine and phenolphthalein

Ultra ZX Supplements D-0991-2015

Class I · High risk Terminated Mar 6, 2015

MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION, USP, 10 mg/mL; 100 mL bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC…

Reason Labeling: Wrong Bar Code: There is a potential for some units to be mislabeled with an incorrect barcode on the immediate container that scans as…

Hospira Inc. NDC 0409-6727-23 D-1076-2015